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| LEADER |
03230nam a2200733Ia 4500 |
| 001 |
10.4155-bio-2021-0039 |
| 008 |
220427s2021 CNT 000 0 und d |
| 020 |
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|a 17576180 (ISSN)
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| 245 |
1 |
0 |
|a Quantification of abemaciclib and metabolites: Evolution of bioanalytical methods supporting a novel oncolytic agent
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| 260 |
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0 |
|b Future Medicine Ltd.
|c 2021
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| 856 |
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|z View Fulltext in Publisher
|u https://doi.org/10.4155/bio-2021-0039
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3 |
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|a Aim: Bioanalytical methods undergo many revisions and modifications throughout drug development to meet the objectives of the study and development program. Results: Validated LC-MS/MS methodology used to quantify abemaciclib and four metabolites in human plasma is described. The method, initially validated to support the first-in-human study, was successfully modified to include additional metabolites as in vitro and in vivo information about the activity and abundance of human metabolites became available. Consistent performance of the method over time was demonstrated by an incurred sample reanalysis passing rate exceeding 95%, across clinical studies. An overview of the numerous methods involved during the development of abemaciclib, including the quantification of drugs evaluated as combination regimens and used as substrates during drug-drug interaction studies, is presented. Conclusion: Robust bioanalytical methods need to be designed with the flexibility required to support the evolving study objectives associated with registration and post-registration trials. © 2021
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| 650 |
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|a abemaciclib
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|a abemaciclib
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|a aminopyridine derivative
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| 650 |
0 |
4 |
|a Aminopyridines
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| 650 |
0 |
4 |
|a analytic method
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| 650 |
0 |
4 |
|a antineoplastic agent
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| 650 |
0 |
4 |
|a Antineoplastic Agents
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| 650 |
0 |
4 |
|a Article
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| 650 |
0 |
4 |
|a benzimidazole derivative
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| 650 |
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4 |
|a Benzimidazoles
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| 650 |
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4 |
|a bioanalysis
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| 650 |
0 |
4 |
|a chemical structure
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| 650 |
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4 |
|a Chromatography, High Pressure Liquid
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| 650 |
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4 |
|a clinical sample analysis
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| 650 |
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4 |
|a combination drugs
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| 650 |
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4 |
|a controlled study
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| 650 |
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4 |
|a drug isolation
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| 650 |
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|a drug metabolite
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| 650 |
0 |
4 |
|a drug stability
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| 650 |
0 |
4 |
|a drug structure
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| 650 |
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4 |
|a first in human study
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| 650 |
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4 |
|a fit-for-purpose
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| 650 |
0 |
4 |
|a hemolysis
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| 650 |
0 |
4 |
|a high performance liquid chromatography
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| 650 |
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4 |
|a human
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|a Humans
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4 |
|a in vitro study
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| 650 |
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|a in vivo study
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| 650 |
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4 |
|a incurred sample reanalysis
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| 650 |
0 |
4 |
|a limit of quantitation
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| 650 |
0 |
4 |
|a liquid chromatography
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| 650 |
0 |
4 |
|a lsn 2389567
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| 650 |
0 |
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|a lsn 2839567
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| 650 |
0 |
4 |
|a lsn 2878851
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| 650 |
0 |
4 |
|a lsn 3106726
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| 650 |
0 |
4 |
|a lsn 3106729
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| 650 |
0 |
4 |
|a measurement accuracy
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| 650 |
0 |
4 |
|a metabolism
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| 650 |
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4 |
|a metabolites
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| 650 |
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4 |
|a Molecular Structure
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|a oncology
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| 650 |
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|a plasma
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| 650 |
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4 |
|a quality control
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| 650 |
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|a quantitative analysis
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| 650 |
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4 |
|a selectivity
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| 650 |
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|a storage temperature
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| 650 |
0 |
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|a tandem mass spectrometry
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| 650 |
0 |
4 |
|a thermostability
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| 650 |
0 |
4 |
|a unclassified drug
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| 700 |
1 |
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|a Lee, L.B.
|e author
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| 700 |
1 |
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|a Wickremsinhe, E.R.
|e author
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| 773 |
|
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|t Bioanalysis
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